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cGMP制藥潔凈室整體解決方案：細(xì)胞治療產(chǎn)品、單克隆抗體、疫苗以及口服固體抗病毒藥物的生產(chǎn)
發(fā)布時(shí)間：2022-04-08 17:23:12
● ● 齊 心 協(xié) 力 | 共 渡 難 關(guān) ● ●
目前，全球仍在繼續(xù)競相尋找抗擊COVID-19 爆發(fā)流行的最有效策略。迫切需要有效的公共衛(wèi)生干預(yù)措施和可靠的治療手段來扭轉(zhuǎn)這一激增趨勢，與此同時(shí)也推動(dòng)了多種用于改善患者預(yù)后的藥物開發(fā)。
感染早期進(jìn)行治療是最有希望的，在尋找早期重要的臨床數(shù)據(jù)過程中，發(fā)現(xiàn)當(dāng)前批準(zhǔn)的藥物有新的適應(yīng)癥（又稱藥物再利用）。基于這個(gè)情況，把早期治療中，對(duì)人體安全有效的藥物分子進(jìn)行聯(lián)合用藥，用于各種篩選試驗(yàn)。據(jù)說這是一種具有成本效益的藥物開發(fā)技術(shù)，相比新療法可以更快地治療新冠肺炎患者。
人類與COVID-19的斗爭仍在繼續(xù)，從長遠(yuǎn)角度來看，接種新冠疫苗是最有效的預(yù)防手段，它有助于個(gè)體產(chǎn)生免疫力，在不良事件發(fā)生時(shí)使個(gè)人感染風(fēng)險(xiǎn)降到最低。疫苗是一種生物物質(zhì)，在外來入侵物質(zhì)（如病毒）刺激身體后做出應(yīng)答并產(chǎn)生抗體?？贵w是由免疫B細(xì)胞天然產(chǎn)生的蛋白質(zhì)，其主要機(jī)制是通過與病毒部分特異性結(jié)合并阻止其進(jìn)入細(xì)胞，從而免于感染或者控制感染發(fā)展為疾病。大多數(shù)獲得批準(zhǔn)的疫苗基本是通過皮下注射和肌肉注射這兩種方式進(jìn)行接種。
通常，這些抗體在接種疫苗或感染后自然產(chǎn)生，但也可以在實(shí)驗(yàn)室中通過生物工程進(jìn)行制備。實(shí)驗(yàn)室制備的抗體稱為單克隆抗體 (mAb)，其產(chǎn)生的方式主要通過靜脈注射以及注射給藥。
盡管最近全球疫情有所改善，但許多國家仍面臨著早期治療需求無法滿足的困境，早期檢測對(duì)于避免產(chǎn)生重癥病例和免于住院治療具有重要意義。因此，隨著治療方法的不斷研究，抗病毒的口服固體制劑(OSD)出現(xiàn)并應(yīng)用。第一個(gè)用于早期COVID-19治療的抗病毒口服藥物是由默克公司研發(fā)的莫努匹韋，臨床數(shù)據(jù)表明，在治療初期或病毒仍在復(fù)制的階段，該藥品具有很高的治療療效，這種藥物會(huì)增加病毒RNA突變的頻率并削弱病毒復(fù)制。
參考文獻(xiàn):
1. Brande, D., Milholland, D., & Haycocks, N. (2017). Why is 90 FPM Considered Standard for Cleanroom Airflow?. ISPE. Retrieved from: https://ispe.org/pharmaceutical-engineering/march-april-2017/why-90-fpm-considered-standard-cleanroom-airflow
2. Channel News Asia (2021). Merck COVID-19 pill sparks calls for access for lower income countries. Retrieved from: https://www.channelnewsasia.com/world/merck-covid-19-pill-sparks-calls-access-lower-income-countries-2250266
3. COVID-19 Prevention Network. (n.d.). The Science of COVID-19 Vaccines and Antibodies. Retrieved from: https://www.coronaviruspreventionnetwork.org/coronavirus-vaccine-and-antibody-science/
4. Cumbers, John (2020). Timeline Shows 3 Paths To COVID-19 Treatment And Prevention (Infographics). Forbes. Retrieved from: https://www.forbes.com/sites/johncumbers/2020/03/25/timeline-shows-3-paths-to-COVID-19-treatment-and-prevention-infographic/?sh=25e975ad4789
5. Institute of Environmental Sciences and Technology. (2001). FED-STD-209E. Retrieved from: https://www.iest.org/Standards-RPs/ISO-Standards/FED-STD-209E
6. International Organization for Standardization. (2015). ISO 14644-1:2015, Cleanrooms and associated environments - Part 1: Classification of air cleanliness by particle concentration (2nd ed.). ISO 2015.
7. Naughton, P. (2019). History of Cleanrooms. ASHRAE Journal. Retrieved from: https://www.ashrae.org/file%20library/technical%20resources/ashrae%20journal/125thanniversaryarticles/38-54_naughton_historical_v2.pdf
8. Ramirez, J., Sharpe, L., & Peppas, N. (2017). Current state and challenges in developing oral vaccines. Advanced Drug Delivery Reviews, 114, 116-131. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132247/
9. U.S. Department of Health and Human Services. (2004). Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. Food and Drug Administration. Retrieved from: https://www.fda.gov/media/71026/download
10. Vaccines Europe. (2020). How are vaccines produced? Retrieved from: https://www.vaccineseurope.eu/about-vaccines/how-are-vaccines-produced
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